Page 2 - Standard Operating Procedures (SOPs)

Standard Operating Procedures (SOPs) for Ethical approval

The objective of this SOP is to achieve effective functioning of the National
Research Ethics Committee (NREC) (Annexure-F) so that a quality and
consistent ethical review mechanism for conducting research studies involving
human subjects and biomedical research is in place.

All research projects for ethical approval should be submitted in the prescribed
Application Form which is available in BMRC office and in the website
(www.bmrcbd.org). It is requested to go through the instruction before preparing
the Research proposal for submission.

Research proposal submitted to Bangladesh Medical Research Council (BMRC)
for ethical approval should be methodologically sound and scholarly standard and
approved by valid scientific review committee. If the proposal is not approved by
any valid Scientific Review Committee than it should be approved by the
Scientific Review Committee of BMRC before submission to NREC. Principal
Investigator will be informed at time of any comments/queries arisen. NREC will
be give the final Ethical Approval after considering the justification given / points
addressed on the ethical issues of the research proposal.

Scientific Review Committee will justify the research proposal is of good scientific
quality, scientific value, validity and feasibility of the protocol and cited relevant
scientific literature (if any) on of proposed research as well as ethical issues by
peer review process.

The NREC will conduct meeting in every 2 (two) months. The frequency of
meetings may increased depending on the number of applications. All decisions
will be communicated to the Principal Investigator in writing.

All relevant documents should be enclosed with Application Form. Required
number of copies of the proposal (soft & hard copy) along with the formal
application / letter and documents in prescribed format (all must be duly signed
by the Principal Investigator (PI) and Co-investigators / Collaborators) should be
forwarded to the Members/Secretary of the NREC.

Chairperson’s Review and Expedited Review:

Expedited Review will be given when the research proposal is approved by
valid Scientific Review Committee – as methodologically sound, without any
intervention and risk of distress or injury, physical or psychological to the
subjects. The expedited proposal with justification for expedition should be
placed in the next NREC meeting.

SOP OF BMRC ETHICAL GUIDELINE Page 1